Waste management system

ABSTRACT

A waste management system includes a waste transport device and a waste collection device. The waste transport device may include a first connector member configured for releasable connection to a second connector member on the waste collection device. The system may also include an insertion device to facilitate insertion of the waste transport device into the rectum of a patient.

PRIORITY

This application claims the benefit of priority to U.S. ProvisionalPatent Application No. 60/958,217, filed Jul. 3, 2007, and to U.S.Provisional Patent Application No. 60/829,758, filed Oct. 17, 2006, eachof which is incorporated by reference into this application as if fullyset forth herein.

BACKGROUND

Waste management systems are important in the healthcare field,particularly for patients that are unable to care for themselves. Suchpatients may suffer from incontinent diarrhea or like maladies and, dueto their condition (e.g., severe burns, surgical incisions, etc.), maybe susceptible to infections should the fecal matter come in contactwith an open wound, burn, surgical site, etc. Moreover, healthcareprofessionals that come in contact with the fecal matter while attendingto the patient may be susceptible to disease and/or the spreadingthereof. Thus, a suitable waste management system, at minimum,substantially contains fecal matter within a closed system so as toavoid, for example, substantial skin breakdown, infection risk,cross-contamination of pathogens, problematic patient clean-up, patientdiscomfort, etc. While fecal management systems are described in theart, many known issues remain unsolved or unaddressed.

The following references relate to fecal management systems orcomponents thereof: U.S. Pat. No. 5,569,216 to Kim; U.S. Pat. No.6,527,755 to Salama; U.S. Pat. No. 7,147,627 to Kim et al.; U.S. PatentApplication Publication No. 2005/0054996 to Gregory; U.S. PatentApplication Publication No. 2005/0137526 to Machado et al.; U.S. PatentApplication Publication No. 2006/0189951 to Kim et al.; U.S. PatentApplication Publication No. 2006/0271087 to Von Dyck et al.; U.S. PatentApplication Publication No. 2007/0049878 to Kim et al.; and U.S. PatentApplication Publication No. 2007/0149922 to Schneider et al., each ofwhich is incorporated by reference in its entirety into thisapplication.

Applicants have recognized that it would be desirable to provide a wastemanagement system that is robust, comfortable for the patient,eliminates known issues and has features that facilitate its use,embodiments of which are described herein.

BRIEF SUMMARY

Accordingly, a waste management system is described herein, the systemincluding a waste transport device and a waste collection device. Thewaste transport device may include a first connector member configuredfor releasable connection to a second connector member on the wastecollection device. The system may also include an insertion device tofacilitate insertion of the waste transport device into the rectum of apatient.

In one embodiment, a waste management system includes a waste transportdevice, including a collection member with a distal end opening having afirst cross-sectional area and a proximal end opening having a secondcross-sectional area less than the first cross-sectional area, aretention cuff disposed about an outer surface of the collection member,and a waste collection device.

In another embodiment, a waste transport device includes a distalsection defining a distal end opening having a first cross-sectionalarea and a proximal end opening having a second cross-sectional arealess than the first cross-sectional area, the distal section includingan inflatable retention cuff, a proximal section including a flushlumen, a connector coupled to a proximal end of the proximal section,and an intermediate section connecting the proximal section to thedistal section, the intermediate section including a transitioningcross-sectional shape from a proximal end to a distal end. In anotherembodiment, a waste transport device includes a collection memberincluding a lumen connecting a distal end opening to a proximal endopening and a retention cuff disposed about an outer surface of thecollection member, the retention cuff including a pain relief drug.

In one embodiment, a method of managing the fecal material of a patient,includes inserting a distal section of a waste transport system in acollapsed configuration into a patient's rectum, the distal section inan expanded configuration defining a distal end opening having a firstcross-sectional area and a proximal end opening having a secondcross-sectional area less than the first cross-sectional area, thedistal section including an inflatable retention cuff, removing theinsertion device from the waste transport system, and inflating theretention cuff to a first inflated configuration.

In another embodiment, a method of connecting a waste transport deviceto a waste collection device includes associating a first connectorcoupled to the waste transport device with a second connector coupled tothe waste collection device by aligning an aperture of the firstconnector with an aperture of the second connector and pressing an endof one or more locking arms of the first connector into slots of thesecond connector, and sliding the first and second connectors to alignthe apertures with a central lumen of the waste transport device and anopening of the waste collection device.

These and other embodiments, features and advantages will become moreapparent to those skilled in the art when taken with reference to thefollowing more detailed description in conjunction with the accompanyingdrawings that are first briefly described.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a waste management system.

FIG. 1B is a perspective view of the proximal end of the system of FIG.1 with the waste transport device separated from the waste collectiondevice.

FIG. 2A is a longitudinal cross-sectional perspective view of a distalsection of a waste transport device.

FIG. 2B is a longitudinal cross-sectional side view of a distal end ofFIG. 2A.

FIG. 2C is a perspective view of one embodiment of a retention cuff fora waste transport device.

FIG. 2D is a perspective view of another embodiment of a retention cufffor a waste transport device.

FIG. 2E is a perspective view of yet another embodiment of a retentioncuff for a waste transport device.

FIG. 2F is a perspective view of FIG. 2B.

FIG. 2G is a top view of FIG. 2B.

FIG. 2H is a side view of FIG. 2B.

FIG. 2I is an axial cross-sectional view of a section of a wastetransport device.

FIGS. 3A-D illustrate stages of deflation and folding of a retentioncuff of a waste transport device.

FIG. 4A-B are perspective views of a waste transport device with aproximal cuff.

FIG. 4C is one embodiment of an inflatable retention cuff.

FIGS. 5A-D are perspective views of different embodiments of acollection member.

FIG. 6 is a cross-sectional view of one embodiment of a single piececollection member and sphincter section.

FIGS. 7A-B are perspective views of another embodiment of a single piececollection member and sphincter section.

FIG. 7C is a perspective view of one embodiment of a retention cuff.

FIG. 7D is a perspective view of one embodiment of a waste managementsystem.

FIGS. 7E-G are cross-sectional views of different regions of the wastemanagement system of FIG. 7D.

FIG. 8A is a perspective view of another embodiment of a wastemanagement system.

FIG. 8B is a partial view of a single piece collection member andsphincter section of the waste management system of FIG. 8A.

FIG. 8C is a cross-sectional view of the extracorporeal section of thewaste management system of FIG. 8A.

FIG. 8D is a cross-sectional view of the waste transport device of thewaste management system of FIG. 8A.

FIG. 9A is a perspective view of one embodiment of a waste managementsystem with a valved connection system.

FIGS. 9B-D are enlarged views of the connection system of FIG. 9A atdifferent stages of connection between the waste transport device andwaste collection device.

FIGS. 10A-B are perspective views of another embodiment of a connectionsystem for a waste management system.

FIGS. 11A-D are perspective views of another embodiment of a connectionsystem for a waste management system.

FIG. 12 is a perspective view of yet another embodiment of a connectionsystem for a waste management system.

FIGS. 13A-C are perspective view of another embodiment of a connectionsystem for a waste management system.

FIGS. 14A-D are perspective views of still another embodiment of aconnection system for a waste management system.

FIGS. 15A-D are perspective views of one embodiment of an insertiondevice for a waste management system.

FIGS. 16A-C are perspective views of another embodiment of an insertiondevice for a waste management system.

FIGS. 17A-D are perspective views of another embodiment of an insertiondevice for a waste management system.

FIGS. 18A-C are perspective views of yet another embodiment of aninsertion device for a waste management system.

FIGS. 19A-B are perspective views of still another embodiment of aninsertion device for a waste management system.

FIGS. 20A-C are perspective views of another embodiment of an insertiondevice for a waste management system.

FIG. 21 is a perspective view of another embodiment of an insertiondevice for a waste management system.

DESCRIPTION

The following description should be read with reference to the drawings,in which like elements in different drawings are identically numbered.The drawings, which are not necessarily to scale, depict selectedembodiments and are not intended to limit the scope of the invention.The description illustrates by way of example, not by way of limitation,the principles of the invention. This description will clearly enableone skilled in the art to make and use the invention, and describesseveral embodiments, adaptations, variations, alternatives and uses ofthe invention, including what is presently believed to be the best modeof carrying out the invention.

As used herein, the terms “about” or “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein. Also, as used herein, the terms “patient”,“host” and “subject” refer to any human or animal subject and are notintended to limit the systems or methods to human use, although use ofthe subject invention in a human patient represents a preferredembodiment.

The waste management system described herein generally includes a wastetransport device and a waste collection device. The waste transportdevice includes a distal end section, referred to herein as “the rectalsection,” configured for disposition in a patient's rectum to begintransport of fecal material from a patient to a waste collection device;a section proximal of the rectal section, referred to herein as “thesphincter section,” configured for disposition in a patient's analcanal; and a section proximal of the sphincter section, referred toherein as “the extracorporeal section,” having a majority of its lengthoutside of the patient. The proximal end of the waste transport deviceis configured to connect to a waste collection device, including acollection container. In certain embodiments, the waste managementsystem includes a connection system for selective coupling of the wastetransport device to the waste collection device and/or an insertiondevice to facilitate insertion of the waste transport device into apatient. Embodiments of these and other features of a waste managementsystem are described herein.

With reference to FIG. 1A, a waste management system 10 includes a wastetransport device, including a generally tubular body (e.g., catheter)12, having a distal end 14 and a proximal end 16, and a waste collectiondevice, including a collection container 30. Positioned at the distalend 14 of the body 12 is a rectal section 18, including a collectionmember 32 and a retention cuff 24 disposed about an outer surface of thecollection member 32 (FIG. 2). Proximal of the rectal section is asphincter section 20, particularly adapted for disposition in the analregion of a patient, and an extracorporeal section 22 generallypositioned outside of the patient's body when the system is in use(although a portion thereof may be inside). In one embodiment, thecollection member 32, sphincter section 20 and extracorporeal section 22are made of a material (e.g., silicone) with the same durometer (e.g.,about 50 Shore A), while the retention cuff 24 is made of a material(e.g., silicone) with a different durometer (e.g., about 35 Shore A). Inanother embodiment, each of the aforementioned components are made of amaterial (e.g., silicone) with the same durometer (e.g., about 50 ShoreA). A body connector 26 is coupled to a proximal end of theextracorporeal section 22 and is configured for quick, secure couplingto a collection container connector 28 to place the body 12 in fluidcommunication with a collection container 30. Various examples ofconnector embodiments are described in detail below. The body 12generally has a plurality of lumens extending along at least a portionof its length, including, for example, a central lumen 34 for passage offecal material from the patient to the collection container 30, aninflation lumen 36, a sampling lumen 38, and a flush lumen 44, each ofwhich is discussed in detail below.

With reference to the rectal section 18 of the body 12, shown in FIGS.2A-2B, the collection member 32 has a distal opening 31 that, whenpositioned for normal use, opens into the rectum of a patient, and aproximal opening 33 that connects to the sphincter section 20. In oneembodiment, the proximal opening 33 has a cross-sectional area that isless than a cross-sectional area of the distal opening. For example, theproximal opening 33 may have an inner diameter less than the innerdiameter of the distal opening 31. Such a configuration imparts to thecollection member 32 a tapered shape (e.g., a funnel), which is believedto aid in the flow of waste material from the patient into the body 12.It is noted that the tapered shape according to one embodiment is afrusto-conical shape. In one embodiment, the collection member 32 isformed from one or more materials having a durometer sufficiently hardto prevent premature closure of the distal opening 31, therebypermitting safe passage of fecal material from the patient regardless offorces acting on the collection member 32. For example, the collectionmember may be made from a material selected from polyurethane, siliconerubber, natural rubber latex, synthetic rubber, guayule rubber, 80 SHpolydimethylsiloxane, fumed silica, polyvinyl chloride (PVC), andcombinations thereof. In one embodiment, the collection member 32includes an annular ring disposed on the distal end thereof, the annularring including a plurality of openings about its perimeter, which areconnected to lumens through a wall of the collection member that mayconnect to one or more lumens disposed in the sphincter section and/orextracorporeal section. For example, the lumens through the wall of thecollection member could extend through the sphincter section, all ofwhich could connect to the sampling lumen 38.

In one embodiment, the rectal section 18 includes a split valve/baffleconfigured to control the type of fluid permitted to pass therethrough.For example, the baffle in one embodiment is configured such that aninfusion of medication into the rectum will not open (e.g., flowthrough) the baffle, but a greater volume of fecal material will open(e.g., flow through) the baffle. In one embodiment, the baffle includesa plurality of discs extending alternately from different sides of apassage of the rectal section 18 (e.g., the collection member 32) suchthat the area open for fluid flow is spaced apart therealong. Thus, themedication intended for the patient will remain for a longer periodwithin the rectum. In another embodiment, a duckbill valve is includedin the rectal section 18 to control fluid flow therethrough.

In the embodiment shown in FIGS. 2A-2B, the retention cuff 24 isdisposed about and attached to an outer surface of the collection member32 and includes an inflatable balloon (e.g., conventional ornon-conventional). In some embodiments, the balloon 24 includes a drug,such as a pain relief drug (e.g., lidocaine). The drug may be coated ona surface of the balloon 24 and/or may be incorporated in an inflationliquid (e.g., lidocaine mixture) such that the drug gradually diffusesthrough a wall of the balloon 24. In one embodiment, the retention cuff24 includes a balloon, an outer surface of which is coated withlidocaine, and which is inflated following insertion into the patientwith a lidocaine or a mixture including lidocaine. Surfactants andanti-microbial lubricant coatings may also be disposed on the retentioncuff. Also, a retention cuff balloon may be encased or otherwiseassociated with a foam to maintain the rectal section in its deployedposition within the patient's rectum and to prevent leakage. The foammay include an absorbant material and/or a coating to reduce odor. Inone embodiment, a relatively high viscosity foam is used to inflate theretention cuff, following introduction into the rectum.

FIGS. 2C-2E illustrate embodiments of the rectal section 18 with aretention cuff 24 and a collection member 32. FIG. 2C is similar to FIG.2A, including a collection member 32 with a frusto-conical shape havinga smooth continuous wall (e.g., no pleats or divisions between theproximal and distal openings) and a retention cuff 24 that when inflatedcreates a shoulder 11 at the junction between the cuff 24 and the body(e.g., sphincter section 20). FIG. 2D shows a cuff 24 d with a geometrythat more gradually transitions to the body, the collection member 32 dhaving a bell-shaped configuration (i.e., frusto-conical shape with aflared distal opening) with a smooth continuous wall. FIG. 2E shows cuff24 d surrounding a collection member 32 e that has a trumpet-shapedconfiguration (i.e., a frusto-conical shape with curved sides and aflared distal opening) with a smooth continuous wall. The retention cuffin some embodiments, may also include one or more structural features asdescribed more completely below in connection with FIGS. 5A-5D. Also,the retention cuff may have a tapered shape when inflated such that thediameter or perimeter increases from a proximal end to a distal end.

FIGS. 3A-3D illustrates one embodiment of a rectal section 18 with aretention cuff balloon 24, configured to provide an advantageously smallprofile for insertion. FIG. 3A illustrates the cuff 24 in its inflatedstate. FIG. 3B illustrates the beginning of deflation, showing theconfiguration of the cuff 24, which includes pockets 24′ disposedbetween spaced apart raised sections 24″ about the circumference of thecuff 24. FIG. 3C illustrates further deflation of the cuff 24 as theraised areas 24″ collapse into the lumen of the rectal section 18, thecuff easily folded by bringing together the raised sections 24″, asillustrated in FIG. 3D. It is noted that any of the retention cuffs 24described herein may have a similar configuration to provide a smallprofile for insertion.

FIGS. 4A-4B illustrate embodiments including a proximal cuff 25, showngenerally in FIG. 4A. The proximal cuff 25, which can include aninflatable balloon, is mounted to the body 12 proximally from theretention cuff 24, for example, along the extracorporeal section 22.Thus, when the body 12 is properly inserted, the proximal cuff 25 may belocated between the patient's buttocks. The proximal cuff 25 is adaptedto prevent upward migration of the retention cuff 24 when inserted anddeployed in a patient's rectum and may optionally include anti-odor,moisturizer and/or lubricant coatings. In one embodiment, the proximalcuff has the form of an umbrella, cone, basin, etc. with the wide partfacing the retention cuff in order to capture material that may leakfrom around the body. The cuff in such an embodiment may be made of asoft, absorbent material and is configured to be removable from the bodyin order to replace when necessary, or alternatively may be made of amaterial that is easily cleaned, such as, for example, a soft plasticmaterial.

FIG. 4B illustrates a variation of a distal section of a body 12, whichincludes a retention cuff 24 and a proximal cuff 25 with a tensionmember 27 disposed in the wall of the body (e.g., along a portion of thesphincter section 20) between the cuffs 24, 25. The tension member 27may include one or more elongated members embedded in the wall of thesphincter section and/or coupled to an inner or outer wall thereof. Thetension member may include spaced apart longitudinally oriented members,circumferentially oriented members, helically arranged members,combinations thereof, etc. According to one embodiment, however, thetension member 27 is a helical coil made of shape memory material (e.g.,Nitinol). Adjacent the proximal cuff 25, a sphincter section 29 free ofthe tension member is provided to prevent loss of sphincter tone asdiscussed above.

The tension member 27 has a collapsed configuration with a collapsedperimeter and an expanded configuration with an expanded perimetergreater than the collapsed perimeter. In one embodiment, at least aportion of the tension member 27 is disposed adjacent the retention cuff24 such that when the retention cuff 24 is inflated, the tension memberexpands from the collapsed perimeter to the expanded perimeter.Following inflation of the retention cuff 24 and expansion of thetension member 27, the proximal cuff 25 is inflated. Due to the shapememory material, the tension member 27 will attempt to return to itscollapsed configuration, which due to the connection to the retentioncuff 24 will be resisted. This resistance provides tension between thecuffs 24, 25, which is believed to aid in the prevention of leakage andmigration of the distal end of the body 12.

FIG. 4C illustrates one embodiment of an inflatable retention cuff thatis adapted to occlude the distal opening 31 when activated. Occludingthe lumen 34 of the body 12 may be desirable, for example, totemporarily block reflux and to retain medicants or drugs in the rectalvault. Known systems accomplish the occlusion function by including aninternal balloon in the distal end of a catheter. The presence of aninternal balloon may partially block the lumen of the catheter even whennot inflated and/or may provide a surface for which fecal materialadheres to, resulting in build-up and eventual blockage of the lumen. Inthe embodiment of FIG. 4C, instead of an internal balloon, retentioncuff 80 includes a plurality of lobes 82 that may be expanded from afirst inflated configuration, similar to the retention cuff 24 describedabove, to a second inflated configuration (as shown), converging tocover the distal opening 31 or otherwise block fluid from reaching thedistal opening 31. The expansion from the first inflated configurationto the second inflated configuration can be accomplished by an infusionsystem 84 that indicates to the user the state of the retention cuff 80(i.e., deflated, first inflated configuration, second inflatedconfiguration) based on a pressure reading of the cuff 80. For example,the infusion system 84 could provide a readout of a first volume (e.g.,50 mL) when the lobes 82 are in the first inflated configuration and asecond volume (e.g., 150 mL) when the lobes 82 are in the secondinflated configuration. In another embodiment, a sliding cuff or sleevemay be positioned proximal of the retention cuff 80, the sliding cuffincluding arms or surfaces configured to force the cuff 80 inward uponcontact therewith such that the distal opening 31 is occluded when thesliding cuff impinges on the retention cuff. Thus, for example, afterthe retention cuff 80 has been inflated to the first inflatedconfiguration, the sliding cuff is moved distally at least partiallyover the retention cuff 80 to occlude the opening 31. Thereafter, whenit is desired to remove fecal matter from the rectum, the sliding cuffis moved proximally out of contact with the retention cuff 80 so thatthe distal opening 31 is no longer occluded.

FIGS. 5A-5D illustrate different embodiments of the collection member.FIG. 5A illustrates a collection member 60 with a plurality of spacedapart struts 62 attached at their distal end to a ring 64, which definesthe distal opening 31. The three struts 62 in the embodiment shown aretwisted to facilitate collapse of the retention cuff 24 for insertionand removal of the body from the patient. The proximal end of the struts62 may be coupled to the body just proximal of the rectal section 18(e.g., sphincter section 20) or may extend further along a length of thebody (e.g., through at least a portion of the extracorporeal section 22)to provide structural support thereto. The struts 62 may be embedded inthe wall of the body section(s) or may be coupled to a surface thereof.In the rectal section 18, the twisted struts 62 may, together with theretention cuff 24, define the collection member lumen. Alternatively,the collection member lumen may be defined by another member (e.g., atapered extrusion) to which the struts 62 are attached. The struts 62and ring 64 may be formed from a metal, polymer, or other suitablematerial that provides structural support to the rectal section 18, andmay have a circular cross-sectional shape, rectangular cross-sectionalshape, or any other geometric cross-sectional shape.

FIG. 5B is another embodiment of a collection member with a plurality ofspaced apart struts (e.g., four), the struts 66 remaining untwisted(e.g., substantially aligned along a longitudinal axis) and attachingdistally to the cuff 24 rather than a ring. Of course, a ring could alsobe included and/or a further member as described above in connectionwith FIG. 5A. The struts 66 have an increasing cross-sectional area fromthe proximal end to the distal end and in the embodiment showntransition from a circular cross-sectional shape at the proximal end toan oval cross-sectional shape at the distal end. Other cross-sectionalshapes are also possible, such as those described above in connectionwith FIG. 5A, and are within the scope of the invention. FIG. 5C is anembodiment of a collection member including a helically arrangedelongate member in the form of a coil 68. The coil 68 defines a lumenalong a longitudinal axis thereof and may be attached directly to thecuff 64 or an additional tapered member. In one embodiment, the elongatemember forming the coil 68 is hollow and is attached directly to thesampling lumen 38 to provide access to the patient's rectum for infusionof drugs/fluids and/or extracting samples for testing. FIG. 5D is yetanother embodiment of a collection member. Collection member 70 hasdistal sections removed to facilitate collapse of the rectal section forinsertion and removal. In the embodiment illustrated, the removal ofsections results in a plurality of petals 72 evenly spaced apart aboutthe circumference of the collection member 70. It should be noted,however, that many other types of patterns, including non-uniformpatterns, are also contemplated herein and within the scope of theinvention.

With further reference to the embodiment shown in FIGS. 2A-2B, thesphincter section 20 is disposed between the collection member 32 andthe extracorporeal section 22. The sphincter section 20 in oneembodiment is distinct from the extracorporeal section 22 and/or thecollection member 32 in that the sphincter section is configured tocollapse under lower pressures to preserve the tone/strength of thesphincter when positioned in the patient for extended periods. Forexample, in one embodiment, the material for the collection member 32and sphincter section 20 are the same, but the thickness of the wall ofthe sphincter section 20 is less than the wall of the collection member32. In other embodiments, the material for the sphincter section 20 isdifferent from the material for the collection member 32 (e.g., morecompliant, softer durometer, etc.) In one embodiment, the sphinctersection 20 is made from a material selected from polyurethane, siliconerubber, natural rubber latex, synthetic rubber, 80 SHpolydimethylsiloxane, fumed silica, polyvinyl chloride (PVC), andcombinations thereof.

The shape of the sphincter section 20 may have a cross-sectional shapethat transitions from a distal end 21 to a proximal end 23, such asshown in FIGS. 2A-2B and 2F-2H. For example, the sphincter section 20 inthe embodiment shown has a substantially circular cross-sectional shapeat its distal end 21 and an oval cross-sectional shape at its proximalend 23 that attaches to the extracorporeal section 22. In other words,at its proximal end 23, the sphincter section 20 has a larger diameteralong a first axis (i.e. the z-axis shown in FIG. 2B), than along asecond axis orthogonal to the first axis (i.e. the y-axis shown in FIG.2B). The oval proximal end 23 of the sphincter section matches the ovaldistal end of the extracorporeal section 22 (FIG. 2I), which in oneembodiment maintains this oval cross-sectional shape from the distal endto the proximal end. The transitional shape for the sphincter section 20is advantageous for resisting rotational motion. That is, the sectionsof the system that have oval cross-sections (e.g., the sphincter sectionproximal end 23 and the extracorporeal distal end) are more resistant torotation than sections with circular cross-sections (e.g., the sphinctersection distal end 21 and the collection member proximal end 33). In oneembodiment, the sphincter section 20 has an hourglass shape. As with theembodiment of FIGS. 2A-2B and 2F-2H, the proximal end of the sphinctersection 20 may have an oval cross-sectional shape, while the distal endmay have a circular cross-sectional shape. Alternatively, each of theproximal and distal ends of the sphincter section may have a circularcross-sectional shape to match circular cross-sectional shapes of thedistal end of the extracorporeal section and the proximal end of therectal section, respectively.

In one embodiment, the sphincter section 20 includes a sealing feature,such as a plurality of ribs arranged about the perimeter thereof. Theribs may be spaced apart and inflatable such that the ribs are deflatedfor insertion and inflated upon deployment. When inflated, the ribs mayprovide a seal and/or prevent rotational movement of the sphinctersection 20. The ribs may be arranged substantially parallel to alongitudinal axis of the sphincter section 20, circumferentially aboutthe perimeter of the sphincter section 20, diagonally, helically,combinations thereof, etc. In one embodiment, anti-twist rings aredisposed about sections of the distal end of the system, such as thesphincter section and the distal end of the extracorporeal section 22.The rings may be longitudinally spaced from one another and may beinflatable similar to the ribs. The rings and/or ribs may beincorporated along the distal end of the system to provide ananti-rotating function. Further, the rings and/or ribs may include areinforcing feature, such as a hard material (e.g., wire), to preventcollapse of the system lumen transporting fecal material from thepatient. In one embodiment, a stiff tube or coiled, flexible spring isdisposed in a wall of a section of the waste transport device or alongan internal surface thereof.

With reference to FIGS. 2B and 2I, inflation lumen 36 andirrigation/sampling lumen 38 can be located adjacent and parallel tolumen 34 and on opposite sides thereof. The inflation lumen 36 and theirrigation/sampling lumen 38 can each be a flexible cylindrical tubeextending along and integrally molded with, embedded into, or otherwiseattached to an inner surface of at least a portion of the rectal section18, sphincter section 20 and extracorporeal section 22. The distal endof the inflation lumen 36 is in fluid communication with the interior ofthe retention cuff balloon 24, while the proximal end of the inflationlumen 36 diverges from the extracorporeal section 22 outside of the bodywhen the system is properly inserted. An inflation port 40 is attachedto the proximal end of the inflation lumen and may include a luer-styleconnector for connection to a syringe or other device for selectivelyinflating and deflating retention cuff balloon 24. The distal end of theirrigation/sampling lumen 38 extends through the rectal section 18 andhas a distal opening positioned adjacent the distal opening 31 of thecollection member 32 so that fluids may be drawn from the patienttherethrough. The proximal end of the irrigation/sampling lumen 38,similar to that of the inflation lumen, diverges from the extracorporealsection 22 and terminates at an irrigation/sampling port 42. The port 42may similarly include a luer-style connector for connection to a syringeor other device so that, for example, a medication or irrigant may beinfused into the patient's rectum, or a fecal matter sample may beextracted from the patient's rectum. In one embodiment, both theinflation lumen 36 and sampling lumen 38 are polyurethane or siliconetubes, having sizes in the range of about 5 Fr to about 10 Fr, forexample, a 6 Fr inflation lumen and an 8 Fr sampling lumen.

Also, as seen best in FIGS. 2A and 2F, the extracorporeal section 22 caninclude a flush lumen 44 disposed along a length of the extracorporealsection 22 in parallel with the central lumen 34. The flush lumen 44 isconfigured to flush and clean the central lumen 34 as necessary. Forexample, it may be desired to periodically flush the lumen 34 of thebody 12 in order to prevent bacterial contamination and to also aid inreduction of odor due to fecal build up. In one embodiment, the flushlumen 44 is closed at a distal end (e.g., the distal end of theextracorporeal section 22) and connects at a proximal end to a flushport 46 coupled to, and extending through, a wall of the extracorporealsection 22 (FIG. 1) that provides access for a syringe or other devicefor inputting a desired cleansing fluid into the flush lumen 44. A portcover 48 (FIG. 1) of any suitable variety may be used that is configuredto sealably close and open the flush port 46. Referring to FIG. 2A, tofacilitate flushing of the central lumen 34, the flush lumen 44 can beperforated with a plurality of apertures 50 positioned along the lengthof the flush lumen 44. In one embodiment, the apertures 50 are groupedinto aperture groups 52, such as groups of four, spaced from one anotheralong the length of the flush lumen. The apertures may be arrangedsubstantially linearly, as shown, or may be otherwise disposed, forinstance, in circular patterns, along separate or continuous curves,etc.

The collection member 32 and sphincter section 20 may be formed togetherinto a single piece, such as member 120, shown in FIG. 6. Member 120includes a collection member 32 that is unattached to the sphinctersection 20 at its proximal end, the attachment occurring only at adistal end where the member 120 forms a rolling portion 122. Thus, thewall 121 defining the lumen through member 120 extends from a proximalend 118 to the distal end of the collection member 32, turning back atthe rolling portion 122 toward the sphincter section 20, and terminatingat a distal end 119 where it attaches to a proximal end of a retentioncuff 24 (the retention cuff 24 having a distal end attached adjacent tothe rolling portion 122). This configuration permits free motion andmovement of the sphincter section 20 with respect to the retention cuff24 such that the cuff is not significantly displaced (if at all) whenthe sphincter section 20 is twisted (as represented by arrow 8 and thedotted lines) or pulled axially, thereby isolating potential loads fromthe retention cuff 24, rather than transferring loads thereto.Applicants believe that by generally preventing the transfer of loadsfrom proximal sections of the waste transfer member to the retentioncuff, several benefits may be realized, such as, for example,minimization of leakage around the retention cuff and minimization ofpressure exerted on the rectal vault (thereby reducing the incidence ofpressure necrosis).

Further, a distal-only attachment configuration enables movement of atool 112 over the length of the member 120 to facilitate insertion andremoval of the waste transport device, as well as “milking” of thecollection member 32. In particular, a tool 112 may include an end piece116 coupled to an elongate member 114, the end piece 116 having across-section similar to the cross-section of the member 120, a sizeless than that of the collection member 32 in its expandedconfiguration, and a rigidity greater than that of the collection member32. For example, if the member 120 has a generally hourglass shape asshown in FIG. 7, the end piece 116 of the tool 112 can be circular witha diameter generally equal to the desired insertion diameter for thecollection member 32. Thus, insertion is facilitated by merely pushingon the proximal end of the elongate member 114 such that a force isexerted on the rolling portion 122 from an inner surface thereof by theend piece 116, while the distal end of the collection member 32 ismaintained in a collapsed configuration with a lower profile than thatof the collection member in its expanded configuration. Followinginsertion, the tool 112 may be slid in a proximal direction while themember 120 is maintained in position in the patient to permit expansionof the collection member 32 to its expanded configuration. During use,the member 120 may be “milked” by sliding the tool 112 over the member120 and performing successive axial movements, distal to proximal, tomove the waste through the lumen of the member 120. To remove the wastetransport device, the tool 112 is slid over the member 120 to the distalend rolling portion 122 in order to collapse the collection member 32 tothe collapsed configuration having a suitable insertion/removaldiameter.

In another embodiment, collection member 32 and sphincter section 20 areformed into a continuous member 90, shown in FIGS. 7A-7B. In theembodiment shown, member 90 includes a stiffening ring 92 around acircumference of the collection member 32 and relief sections 93disposed approximately equidistantly between the inflation lumen 36 andthe sampling lumen 38 to facilitate collapse of the collection member 32for delivery and withdrawal from the patient's rectum. The reliefsections 93 may be raised portions of the collection member innersurface, for example, having a semi-circular cross-section along itslength. The distal end of the collection member includes a lip 96 aboutthe circumference of the distal opening 31. Openings 94 in a wall of thecollection member are configured to pass air or fluid from the inflationlumen 36 to a surrounding retention cuff (it is noted that the distalend of the inflation lumen shown open in these figures will be closed ina final assembly so that air or fluid will be forced out of the openings94). The collection member 32 has a generally frusto-conical shape,while the sphincter section 20 has a generally cylindrical shape. FIG.7C is one embodiment of a retention cuff 123, having a bulb-likegeometry along a body 124 and a tapered distal end 125. The retentioncuff 123 is configured to fit over the collection member 32 and isattached at distal end 125 to the distal end of the collection member 32and at proximal end 129 to a proximal end of the collection member 32.

FIG. 7D illustrates one embodiment of a waste management system 100,including a waste transport device 101 and a waste collection device102. Waste transport device 101 includes member 90 and retention cuff 25of FIGS. 7A-C, an extracorporeal section 22, a connector housing 126,connector collar 127 and connector ball valve 160 (described in moredetail below), and devices for fluid movement, including arm flush lumen131, arm pilot balloon 132 and arm irrigation sleeve 133. Wastecollection device 102 includes a collection container 30, a hub socket35 configured to receive connector housing 126, and hub plug 6 tetheredto the hub socket 35, the hub plug 6 including threads for mating withan interior threaded surface of hub socket 35 in order to seal theopening of the collection container 30. FIG. 7E is a cross-sectionalview of the collection container interface, showing connector housing126 and hub socket 35 in more detail. FIG. 7F is a cut-away view of armflush lumen 131 and its connection to flush lumen 44 of extracorporealsection 22. FIG. 7G is a cross-sectional view of both the arm pilotballoon 132, connected to inflation lumen 36, and arm irrigation sleeve133, connected to sampling lumen 38. It is noted that the hexagonalsection of the arm pilot balloon is configured to bulge outward whenthere is line pressure to indicate such to the user.

Another embodiment of a waste management system is illustrated in FIGS.8A-8D. Waste management system 110 includes waste transport device 111with a relatively shorter length than waste transport device 101 and awaste collection device 109 with a different configuration than wastecollection device 102. In particular, waste collection device 109 has atubular shape with a proximal opening covered by a sealed septum 105. Anodor control filter, made of a material such as carbon, may be embeddedin the wall of the waste collection device 109 or may be covering a fora vent disposed therein. The waste collection device 109 may have acollapsed configuration which expands upon receipt of waste materialtherein, or may have a more rigid configuration (as shown) such that avent in a wall thereof may enhance drainage efficiency.

The waste transport device 111 includes an extracorporeal section 22with a drain tube irrigation port 95, an inflation port 107 and asampling port 108. The inflation port 107 is connected to an inflationlumen 36 extending from the inflation port 107 to the retention cuff 24,while the sampling port 108 is connected to a sampling lumen 38extending from the sampling port 108 to the distal end of the wastetransport device 111. The irrigation port 95, as shown in FIG. 8D, isconnected to a flush lumen with patterned holes along its length toflush the lumen of the extracorporeal section 22. As fluid is introducedthrough the port 95, the fluid extends along the length of the flushlumen entering into the lumen of the extracorporeal section 22 throughthe patterned holes. The irrigation port 95 in one embodiment is anEZ-LOK® Sampling Port. In another embodiment, an EZ-LOK® Sampling Portis also positioned on the extracorporeal section 22 with access to thelumen thereof for periodic sampling of fecal matter therefrom.

As best seen in FIG. 8B, a continuous member 91 includes both thesphincter section 20 and collection member 32. The collection member 32has a wavy perimeter with undulations including peaks and valleys. Thevalleys 97 form crease lines to facilitate collapse of the collectionmember 32 to a collapsed configuration. A retention cuff 24 surroundsthe collection member 32. Collapsible struts 98 are positioned at thepeaks of the perimeter, forming a stiffening area to resist collapse ofthe collection member during use. The struts 98, as shown, extendcircumferentially away from the perimeter along an outer surface of thepeak section and form a recessed region along an inner surface of thepeak section of the collection member. Such a shape is designed to fitin an insertion tool such that collapse of the collection member isfacilitated. In other embodiments, the struts 98 may take a differentgeometric shape or form, depending on the shape/size of the insertiontool and/or desired levels of stiffness for the collection member. Thewaste transport device 111 includes at its proximal end a connectionmember 103 configured for coupling to connection member 104 of the wastecollection device 109, embodiments of which are described in more detailbelow.

In the embodiments described herein, the extracorporeal section 22 mayhave a uniform cross-section along its length (e.g., circular, oval,etc.) or a transitional cross-section similar to the sphincter section20 shown in FIGS. 2A-2B. The extracorporeal section 22 can be formed ofa non-collapsible tube constructed of a material that is sufficientlystiff in order to maintain its shape during use (e.g., to prevent orminimize kinking, to facilitate drainage, etc.), but soft enough to be“milked” by a care professional to force through fecal material whennecessary. For example, in one embodiment, the extracorporeal section ismade from a rubber or plastic material that does not collapse under itsown weight. In one embodiment, the extracorporeal section 22 includesone or more stiffening structures, such as inflatable ribs, metal wiresor ribbons, axially positioned rings, etc., to assist in preventingcollapse of the lumen 34. As with the ribs discussed above, thestiffening structures may be disposed longitudinally, circumferentially,helically, etc.

The “milking” in one embodiment is performed by a clamp tool includingopposing first and second arms attached to a handle, the first andsecond arms arranged approximately perpendicular to the handle with agap therebetween. A portion of the sphincter section 20 orextracorporeal section 22 is placed between the arms and the handle ispulled in a proximal direction to move fecal matter through the sectionmilked. The tool may include a locking feature such that the first armlocks or is coupled to the second arm to clamp a section of the wastetransport device.

The body 12 can be secured to the collection container 30 via respectiveconnectors 26 and 28. With reference to FIG. 1B, the collectioncontainer 30 is in the form of a bag, having an opening 54 located on afront side, which provides access to the interior thereof. In otherembodiments, the collection container 30 may be in other suitable formswith one or more openings therein. Because it is desirable to secure thebody 12 to the collection container 30 so that the central lumen 34 isin fluid communication with the interior of the collection container 30,the connection system positions the lumen 34 substantially in axialalignment with the opening 54 when the body 12 is coupled to thecollection container 30. In one embodiment, the collection container 30is configured to absorb and reduce odor, for example, by providing aventable section including activated charcoal. The activated charcoalcan be changed when desired via interchangeable charcoal cartridges thatare inserted into the collection container 30. The collection container30 can also have a parylene coating, anti-odor coating and/orantimicrobial coating. In addition, the collection container 30 caninclude material in a wall thereof that absorbs/binds odor. Suitableexamples of coatings/materials include those disclosed in U.S. Pat. No.6,579,539, U.S. Pat. No. 6,596,401, U.S. Pat. No. 6,716,895, U.S. Pat.No. 6,949,598, and U.S. Pat. No. 7,179,849, each of which isincorporated by reference in its entirety into this application.

In the embodiment of FIG. 1B, the collection container connector 28includes a slide mechanism adapted to receive and retain an annularflange extending from the body connector 26. Accordingly, the body 12can be secured to the collection container 30 by sliding the annularflange section of the catheter connector 26 into a slot or groovedsection of the container connector 28. When it is desired to separatethe body 12 from the collection container 30, the body connector 26 canbe slid upwards, out of the container connector 28, thereby disengagingthe body 12 from the collection container 30. Because it is oftendesirable to prevent leakage from the body 12 and the collectioncontainer 30 upon separation of the body 12 from the collectioncontainer 30, closures valves 56 and 58 can be provided in the proximalopening of each. In one embodiment, the closure valves 56 and 58 aresplit polymeric coverings, such as septums, that open when fluidpressure acts thereon from the fecal matter and/or flush lumen fluid incentral lumen 34. In other embodiments, the valves open upon connectionbetween the body 12 and collection container 30. For example, amechanism on connector 26 and/or 28 will open one or both of the valves56, 58 when the annular flange of the connector 26 is slid into the slotof the connector 28.

Another embodiment of a connection system for the waste managementsystem is shown in FIGS. 9A-9D. A catheter connector 126 includes a ballvalve 160 that is rotationally held in the catheter connector 126 andhas an internal channel 162 extending between openings 164 and 166located on opposite ends of the ball valve 160. A nub 168 extends from aportion of the ball valve 160. FIG. 9B shows the configuration of theball valve 160 when the connector 126 is in a sealed position andseparated from a collection container. Here, the openings 164 and 166and the interior channel 162 do not align with the central lumen 34 ofthe catheter, thereby sealing the proximal opening of the body 12.However, in the open position, as illustrated FIGS. 9C and 9D, the ballvalve 160 is rotated so that the channel 162 and openings 164 and 166are aligned with the central lumen 34 when the connector 126 isconnected to the collection container connector 128. A divot 170 locatedin the container connector 128 is configured to trap and move the nub168 when the catheter connector 126 is secured to the containerconnector 128. As shown in FIGS. 9C and 9D, when the container connector128 and the catheter connector 126 are brought together, the nub 168 ismoved rearward, causing the ball valve 160 to rotate to its openposition. In one embodiment, the connection between the body 12 and thecollection container 130 is securely held together by a bayonet typemechanism or other types of known securing mechanisms.

As shown in FIG. 9A, the collection container 130 may include a Velcrostrap 172 adapted to be an effective handle and to securely hang thecollection container 130 from a patient's bed. The Velcro strap 172 canbe fastened at one end to the container connector 128 with a free endincluding a Velcro strip affixed to one side for engagement to acorresponding receiving strip affixed to a part of the strap adjacentthe end fastened to the container connector 128. Thus, attachment to apatient's bed or other structure is easily accomplished by separatingthe free end of the strap 170 from the receiving strip, looping itthrough an opening in the structure, and reattaching the free end to thereceiving strip. Alternatively, the collection container 130 may includea hook or other like member to hang the collection container 130 fromthe patient's bed. The collection container 130 may be substantiallyopaque with a transparent strip 174 extending from a lower portion ofthe container to an upper portion thereof. The transparent strip 174 canbe located on multiple sides of the container (e.g. front, first side,second side and back), or only a single side as shown. The opaqueportion of the container 130 substantially conceals the contents of thecontainer, while the transparent strip 174 provides a means to visuallymonitor the volume of waste in the container so that it can be emptiedbefore reaching a maximum level.

In another embodiment of a connection system for the waste managementsystem, a guillotine connection assembly shown in FIGS. 10A-10E includesa body connector 226 and a container connector 228. The containerconnector 228 includes a first slide 276 held between two sidewalls 278a and 278 b and moveable therealong. An upper end of the first slide 276has a tab 280 for griping and a lower portion of the slide 276 includesan aperture 282. When the first slide 276 is in a closed position, asshown in FIG. 10A, a collection container opening is covered by theslide 276. The first slide 276 is moved upward to place in an openposition, in which the slide aperture 282 is aligned with the collectioncontainer opening. The body connector 226 includes a pair of lockingarms 284 a and 284 b extending from the sides of the connector 226. Asecond slide 286 is held between the locking arms 284 a and 284 b andincludes an aperture 288 located on a lower portion thereof havingapproximately the same size and shape as the aperture 282 on the firstslide 276.

To form a connection between the body 12 and the collection container230, the second slide 286 is positioned such that the ends of thelocking arms 284 a and 284 b are positioned adjacent corresponding slots290 a and 290 b of the container connector 228 and the apertures 282 and288 are aligned. The locking arms, which may include a feature thatindicates a positive connection (e.g., tactile, audible, etc.), are thenpressed into the slots 290 a and 290 b such that the body 12 is coupledto the collection container 230. The tab 280 is then pulled in an upwarddirection, causing both the first slide 276 and the second slide 286 tomove into an open position, in which the lumen 34 of the body 12 isaligned with the collection container opening to place the collectioncontainer 230 in fluid communication with the body 12. In oneembodiment, movement of the tab 280 in an upward direction locks theconnectors 226, 228 together to prevent inadvertent separation duringuse. When it is desired to remove the collection container 230 from thebody 12, the tab 280 is pushed in a downward direction, sealing both theopening of the collection container 230 and the opening in the body 12and unlocking the connectors 226, 228 for separation. In one embodiment,the locking arms 284 a and 284 b include a clamping mechanism that canbe opened by pressing a proximal end toward the connector 226 and closedby releasing the end. Thus, to release connector 226 from connector 228,the clamping mechanism on arms 284 a, 284 b is opened.

A variation of a guillotine connection assembly is shown in FIGS.11A-11D. As seen in FIG. 11A, an ostomy bag flap seal 310 seals theopening of the collection container 330. A body connector 326 coupled tothe body 12 includes a disk 312 positioned on a side of the connector326 opposite the face that can be moved between a sealed position (shownin FIG. 11B) and an unsealed position (shown in FIG. 11C). Nubs 314 aand 314 b extending from opposing sides of the disk 312 are held inrespective tracks 316 a and 316 b of the catheter connector 326,permitting the disk 312 to slide in upward and downward direction, asshown in various stages in FIG. 11D. When the catheter connector 326 isseparated from a container connector 328, the disk 312 is in the sealedposition. The connector 326 is attached to the container connector 328by sliding the track of connector 326 over the rail of connector 328, bypressing the connector 326 onto the connector 328, or other manner ofconnection known to one skilled in the art. Following connection, thedisk is pushed up the tracks 316 a and 316 b to unseal the body proximalopening and place the body 12 in fluid communication with the collectioncontainer 330. FIG. 11C illustrates an embodiment of a hook/handle 316attached to the collection container 330, which may be integral with thecollection container connector 328 and can serve to hold the collectioncontainer 330 on a patient's bed, as well as providing a handle for thecollection container 330.

Yet another manner of connecting a catheter to a collection container isshown in FIG. 12. A container connector 428 attached to a collectioncontainer 430 includes a housing 410 having an opening 412 to theinterior of the collection container and a cap member 414. The capmember 414 can be securely snapped onto the housing 410 over the opening412 to seal the opening 412. A body connector 426 coupled to the body 12includes a reduced diameter section 416 at its proximal end that isconfigured for insertion into the opening 412 of the container connectorhousing 410. Locking tabs 420 a and 420 b are located on opposite sidesof the reduced diameter section 416 and are configured to slide intocorresponding slots 422 a and 422 b extending along the interior of thecontainer connector housing 410. When fully inserted, the locking tabs420 a and 420 b engage notches (not shown) in slots 422 a and 422 b tosecure the catheter to the collection container 430. In addition, thelocking tabs 420 a and 420 b may produce an audible indication to theuser that the tabs have been fully inserted into the slots 422 a and 422b and that the connection is secure. In one embodiment, a ball valve 424is positioned in the connector housing 416 that rotates between a sealedposition when the body 12 is separated from the collection container 430and an unsealed position when the body 12 is secured to the collectioncontainer 430. The catheter connector 426 and the collection containerhousing 410 may also include one or more grips 440 to facilitate use. Inaddition, the connector housing 416 may include one or more integratedports, as shown in FIG. 12. Thus, for example, a first port 442 may bein fluid communication with the irrigation/sampling lumen 38, a secondport 444 may be in fluid communication with inflation lumen 36, and athird port 446 may be in fluid communication with the flush lumen 44.The collection container 430 includes a rigid, curved handle 450 affixedto and extending from a top thereof, which may aid a user in carryingthe collection container 430 for disposal and/or serving as a hook toquickly and easily hang the collection container 430 from a patient'sbed.

FIGS. 13A-13C illustrate an embodiment of a connection system similar tothat of FIG. 12. In this embodiment, a body connector 526, coupled tothe body 12, includes a duckbill valve 510 and a container connector 528includes a concentric tube 512 with an angled face that is configured toforce the valve 510 open upon contact therewith. The duckbill valve 510is sealed when the body 12 is separated from the collection container530 and opens as the end of the body connector 526 is inserted into thecontainer connector 528. In one embodiment, a visual indicator isprovided with the connection system to indicate a proper and secureattachment of the body connector 526 to the container connector 528. Inthe example of FIG. 13, best seen in FIG. 13B, an indicator 514 (e.g., araised surface, a symbol or geometric figure with a different color thanthe surface on which it is placed, etc.) is located on a surface of thereduced diameter section 510 of the body connector 526. A complementaryfeature on the container connector 528, such as an aperture 516 with thesame shape as the indicator 514, provides confirmation to the user of asecure connection when the indicator 514 is fully visible through theaperture 516.

Another example of a connection system is shown in FIGS. 14A-D. Acylindrically shaped body connector 626 includes a flexible tube 610positioned inside a channel. A first annular ring 612 is affixed to adistal end of the flexible tube 610 and to the interior wall of the bodyconnector 626. A second annular ring 614 is affixed to a proximal end ofthe flexible tube 610 and is rotatably held in body connector 626. Asshown in FIG. 14A, the flexible tube 610 is biased in a twisted positionto seal the proximal opening of the body 12. In order to open theproximal opening, the tube 610 is untwisted as shown in FIG. 14C.Untwisting the tube 610 is accomplished by first inserting the end ofthe body connector 626 into the container connector 628 of a collectioncontainer (FIG. 14D) such that a tab 616 of the container connector 628is positioned inside a corresponding slot 618 on the body connector 626,located on the second annular ring 614 (FIG. 14A). Next, the end of thebody connector 626 is rotated, causing the second annular ring 614 andthe proximal end of the flexible tube 610 to also rotate, therebyunsealing the opening of the body 12. Various suitable connectionmechanisms can be used to secure the catheter connector 626 to thecontainer connector 628. For example, FIG. 14D shows a bayonet styleconnection mechanism that gives positive feedback to the user whenconnection is complete. In addition, the collection container openingcan be sealed by various suitable mechanisms, including a standardostomy bag flap as discussed above.

Turning now to FIGS. 15A-15D, one embodiment of an insertion device fora waste management system is illustrated. The insertion device 700 isconfigured to facilitate insertion of a waste transport device.Insertion device 700 includes an inner sleeve 702 and an outer sleeve704, each having a generally tubular configuration and flanges at aproximal end thereof. The outwardly extending flanges of the outersleeve 704 are configured to prevent over-insertion of the device 700,indicating to a user that maximum safe insertion has been reached whenthe flanges are adjacent a patient's buttocks. The outwardly extendingflanges of the inner sleeve 702 provide an indication to the user thatthe retention cuff has moved distally through the distal end of theouter sleeve 704 when the outer sleeve flanges are adjacent thereto. Theproximal end of both the inner sleeve 702 and the outer sleeve 704include respective pairs of c-rings 706 a, 706 b and 708 a, 708 bpositioned on the respective flanges. Each pair of c-rings 706 a, 706 band 708 a, 708 b are separated by a pair of v-cuts 710 and 712 (only oneside of v-cuts shown in FIG. 15A). The v-cuts 710 and 712 facilitatedisassembly of the sleeves 702 and 704 from the body 12 post insertion,as the v-cuts feed into a split section (e.g., an elongate score fromthe v-cut to the distal end of the sleeve) that separates the sleeveinto two pieces. The insertion device 700 is shown on the body 12 in aninsertion configuration in FIG. 15B, a distal end of the outer sleeve704 covering the rectal section 18, the retention cuff 24 held by theouter sleeve 704 in its collapsed configuration. In one embodiment, theouter sleeve 704 is configured to compress the retention cuff 24 inorder to provide a lower profile for the device 700.

FIG. 15C shows the insertion device 700 as it is retracted from therectal section 18, the end of the outer sleeve having a perforatedsection to permit passage of the rectal section 18 therethrough.Retraction of the outer sleeve 704 may occur during insertion due toforces acting on the insertion device 700 or may be manually performedby a user following insertion. FIG. 15D shows retraction of the outersleeve 704 and initial removal of the insertion device 700 from the body12. It should be noted that the retention cuff may self-expand followingretraction of the outer sleeve 704 in some embodiments, and in otherswill require inflation. Following proper positioning of the body 12 inthe patient, the insertion device 700 can be disassembled by graspingthe pair of c-rings 708 a and 708 b and pulling the outer sleeve 704apart along its v-cuts 712, and then grasping inner sleeve 702 in asimilar manner and pulling apart and off of the body 12. Removal of thedevice 700 may occur after only a portion of the outer sleeve 704 isretracted from the rectal section 18 or after the device 700 is slidproximally further along the body 12.

Another embodiment of an insertion device is illustrated in FIGS. 16A-C.The insertion device 800 includes a disposable sleeve with an outerportion 804 folded over an inner portion 802 in a rolling diaphragmarrangement. The inner portion 802 may have a suitable adhesive disposedon an inner surface thereof to prevent migration of the device 800during insertion. A first end of the sleeve, initially inner portion802, includes a pair of inner cuff rings 806 a and 806 b, while a secondend of the sleeve, initially outer portion 804, includes a pair of outercuff c-rings 808 a and 808 b. FIG. 16A shows the device 800 in aninsertion position with the retention cuff 24 folded and held in afolded state by sleeve outer portion 804. To deploy the waste transportdevice in the patient, the outer portion 804 is pulled in a proximaldirection, as shown in FIG. 16B, until fully pulled from over the innerportion 802, as shown in FIG. 16C. In this position, the retention cuff24 is released from its folded position and allowed to expand and/orinflated. The insertion device 800 is removed by pulling the c-rings 808a and 808 b apart so that the v-cuts 810 expand, separating the sleeveinto two pieces, and pulling away from the body 12. FIGS. 17A-17Dillustrate a variation of device 800 with inner cuffs 906 a and 906 bthat have a longer length than cuffs 806 a and 806 b. The length of thecuffs (e.g., in the range of about 1 inch to about 2 inches) providesclamping to prevent migration, thereby potentially eliminating the needfor an adhesive on the inner surface of the inner portion 804. In oneembodiment, the insertion device 800 includes dimpled c-rings to help auser load the catheter correctly. In another embodiment, a reduceddiameter section 912 is included where the inner portion 802 and outerportion 804 of the sleeve meet when in the insertion position. As shownin FIG. 17D, when the outer portion is pulled in the proximal direction,the reduced diameter section 912 may indicate to a user when theinsertion device 800 is fully unrolled to the correct point ofinsertion. The reduced section 912 also provides a narrower entry forthe device 800 at the insertion point.

Another embodiment of an insertion device is illustrated in FIGS.18A-18C. Insertion device 1000 includes a separate inner sleeve 1002 andouter sleeve 1004, similar to the embodiments of FIG. 15. In thisembodiment, a distal end of the outer sleeve 1004 includes a taperedhead 1010 to facilitate insertion by providing a smaller profile. Thetapered head 1010 can also provide a smooth transition from thesphincter section 20 of the catheter and can be constructed of aflexible material with rounded edges to minimize discomfort. Inaddition, the insertion device 1000 can include an increased diameterlimiter flange 1012 extending from a proximal end of the outer sleeve1004. The limiter flange 1012 can be configured to assist a user tolocate a proper insertion depth. For example, the limiter flange 1012can be set at a predetermined distance along the insertion device 1000so that a person administering the body 12 can use to the limiter flange1012 as a reference as to how far the body 12 is inserted into thepatient. The limiter flange 1012 can also limit the depth that that theinsertion device 1000 can be inserted into the patient. FIG. 18B showsthe insertion device 1000 in a retracted configuration with the rectalsection 18 with retention cuff 24 released and expanded. As the outersleeve 1004 is retracted, the head 1010 of the insertion device 1000splits apart at a plurality of tear away seams 1024 to permit relativedistal movement of the body 12.

The insertion device 1000 is removed from the body 12 by pulling theouter sleeve 1002 and inner sleeve 1004 apart at tear zones 1014 and1016, respectively, that begin with corresponding v-cuts 1018 and 1020.In one embodiment, the insertion device 1000 includes one or more “ripstrips” to facilitate disassembly of the insertion device 1000. Anexemplary rip strip 1022, shown pulled away from the outer sleeve 1004,is illustrated in FIG. 18C. One or more rip strips may also be includedon the inner sleeve 1002.

Yet another embodiment of an insertion device is illustrated in FIGS.19A-C. In this embodiment, the insertion device utilizes a scissoraction similar to that of a disposable vaginal speculum. A catheter,such as body 12, has a plunger 1102 disposed about a distal portionthereof, the plunger 1102 including a pair of grips 1104 a and 1104 bextending from its proximal end configured for removing the plunger 1102following insertion of the body 12 in the patient. A scissor device 1106includes a rigid upper arm 1108 and a rigid lower arm 1110 pivotallyconnected to one another at pivot point 1112. A soft, flexible sleeve1114 is positioned around an upper portion of the scissor device 1106,which covers the pinch points of the scissor device 1106 and provides aprotective cover for at least a portion of the body 12 and/or plunger1102 during insertion. As shown in FIG. 19B, squeezing handles 1116 and1118 together causes the pivotal movement of the upper arm 1108 awayfrom the lower arm 1110, which may be limited by the sleeve 1114. Forinsertion, the distal portion of the body 12 and plunger 1102 areinserted into a proximal opening of the scissor device 1106, eitherbefore or after the scissor device 1106 is inserted into a patient. Thehandles of the device 1106 are then squeezed together to facilitateinsertion of the body into the patient. The plunger grips 1104 a, 1104 bextend outward from the plunger and may be spaced from a distal end ofthe body 12 to indicate to the user a proper depth of insertion or toindicate the maximum safe depth of insertion when the grips 1104 a, 1104b come into contact with a proximal end of the device 1106. One or moretear-away bands may be included on the plunger 1102 to facilitateremoval.

Still another embodiment of an insertion device is illustrated in FIGS.20A-20C. Insertion device 1200 includes an upper sleeve 1202 attachedalong one or more tear away seams 1210 to a lower sleeve 1204. A spacer1212 is provided to indicate proper or safe insertion depth of thedevice. A handle 1214 is provided at the proximal end of the lowersleeve 1204 to facilitate handling and insertion. The upper sleeve 1202in one embodiment is made of a material that more flexible than thelower sleeve 1204. In the insertion configuration shown in FIG. 20A, theinsertion device 1200 compresses the folded retention cuff 24 to providea lower profile for easier insertion into the patient. Followinginsertion, the device 1200 is removed by first shearing back the uppersleeve 1202, as shown in FIG. 20B, which splits a tip 1206 to expose theretention cuff 24 and allow it to expand (e.g., unfold). Then, the uppersleeve 1202 is removed from the patient, as shown in FIG. 20C, followedby removal of the lower sleeve 1204.

FIG. 21 illustrates an insertion device 1300 configured similar to asheath introducer or tampon applicator. The distal end of the body 12 isinserted into the device 1300, which may have a lubricious coating on anouter surface thereof. The distal end 1302 has a plurality of petalsthat together maintain the folded profile of the retention cuff 24, butwhich split apart when the body 12 is pushed in a distal direction topermit passage of the body therethrough. To remove, the device 1300 isslid in a proximal direction along the body. The device 1300 may alsoinclude visual depth markers and/or an anchoring mechanism.

While the invention has been described in terms of particular variationsand illustrative figures, those of ordinary skill in the art willrecognize that the invention is not limited to the variations or figuresdescribed. In addition, where methods and steps described above indicatecertain events occurring in certain order, those of ordinary skill inthe art will recognize that the ordering of certain steps may bemodified and that such modifications are in accordance with thevariations of the invention. Additionally, certain of the steps may beperformed concurrently in a parallel process when possible, as well asperformed sequentially as described above. Therefore, to the extentthere are variations of the invention, which are within the spirit ofthe disclosure or equivalent to the inventions found in the claims, itis the intent that this patent will cover those variations as well.Finally, all publications and patent applications cited in thisspecification are herein incorporated by reference in their entirety asif each individual publication or patent application were specificallyand individually put forth herein.

1. A waste management system, comprising: a waste transport device, including a collection member with a distal end opening having a first cross-sectional area and a proximal end opening having a second cross-sectional area less than the first cross-sectional area, a retention cuff disposed about an outer surface of the collection member; and a waste collection device.
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 6. The system according to claim 1, wherein the collection member includes a valve configured to open when contacted by fecal material, but to remain closed when contacted by fluids infused into the patient.
 7. The system according to claim 1, wherein the retention cuff comprises an inflatable balloon.
 8. The system according to claim 7, wherein the balloon includes a drug disposed on a surface thereof.
 9. The system according to claim 7, wherein the balloon is encased in foam.
 10. The system according to claim 7, wherein the balloon is inflatable to a first configuration and a second configuration larger than the first configuration, wherein the second configuration at least partially occludes the distal end opening.
 11. The system according to claim 7, further comprising an inflation lumen in fluid communication with the balloon.
 12. The system according to claim 11, further comprising a sampling lumen having a distal opening positioned adjacent the distal end opening of the collection member.
 13. The system according to claim 1, wherein the collection member has a frutsto-conical shape with a smooth continuous wall.
 14. The system according to claim 13, wherein the collection member includes a flared distal end.
 15. The system according to claim 1, further comprising a proximal cuff disposed proximal of the retention cuff.
 16. The system according to claim 15, wherein a tension member is disposed between the proximal cuff and the retention cuff.
 17. The system according to claim 1, wherein the collection member includes a plurality of spaced apart struts attached at a distal end thereof to a ring defining the distal end opening.
 18. The system according to claim 17, wherein one or more of the struts are twisted about a longitudinal axis.
 19. The system according to claim 1, wherein the collection member comprises a helically arranged elongate member.
 20. The system according to claim 19, wherein the elongate member is hollow and is adapted for fluid flow therethrough.
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 55. A method of managing the fecal material of a patient, comprising: inserting a distal section of a waste transport system in a collapsed configuration into a patient's rectum, the distal section in an expanded configuration defining a distal end opening having a first cross-sectional area and a proximal end opening having a second cross-sectional area less than the first cross-sectional area, the distal section including an inflatable retention cuff; and inflating the retention cuff to a first inflated configuration.
 56. The method according to claim 55, further comprising the step of monitoring the outflow of fecal material from the waste transport system into a waste collection system.
 57. The method according to claim 55, further comprising the step of inflating the retention cuff to a second inflated configuration greater than the first inflated configuration, the retention cuff in the second inflated configuration occluding the distal end opening.
 58. The method according to claim 55, further comprising the step of removing fecal material through a sampling lumen having a distal end adjacent the distal end opening.
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 61. A waste transport device, comprising: a collection member including a lumen connecting a distal end opening to a proximal end opening; and a retention cuff disposed about an outer surface of the collection member, the retention cuff including a pain relief drug.
 62. The system according to claim 1, wherein the collection member includes a stiffening ring positioned about a circumference of the collection member between the distal end opening and proximal end opening.
 63. The system according to claim 62, wherein the collection member further includes two or more relief sections extending along a longitudinal axis of the collection member and spaced apart about the perimeter of the collection member.
 64. The system according to claim 1, wherein the collection member includes a wavy perimeter with undulations including peaks and valleys, the valleys including creases along a longitudinal axis of the collection member, the peaks including collapsible struts extending along the longitudinal axis, the struts forming recessed regions along inner surfaces of the peaks.
 65. The system according to claim 1, wherein the retention cuff comprises a balloon that exhibits, in a deflated state, pockets separated by raised sections, the raised sections folded toward the pockets to provide a low profile retention cuff. 